FDA Adverse Event
Other
Summary report: N
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
MDR report key: 1622460
·
Received February 23, 2010
Report
- Report Number
- 2023826-2010-00177
- Event Type
- Other
- Date Received
- February 23, 2010
- Date of Event
- January 26, 2010
- Report Date
- January 26, 2010
- Manufacturer
- STAAR SURGICAL CO.
- Product Code
- MTA
- PMA / PMN Number
- P030016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY RELEASING THE MICL12.1 IMPLANTABLE COLLAMER LENS INTO THE EYE AND THE LENS WAS INSERTED UPSIDE. THE LENS WAS TORN AS THE SURGEON REMOVED IT FROM THE EYE. NO PATIENT INJURY. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISIAN ICL (IMPLANTABLE COLLAMER LENS) | INTRAOCULAR LENS | MTA | STAAR SURGICAL CO. | MICL12.1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | CARTRIDGE: MODEL SFC-45FP, LOT #UNK| INJECTOR: MODEL MSI-TF, LOT #UNK| FOAM TIP PLUNGER: MODEL UNK, LOT #UNK |